Comparison of efficacy between risperidone and aripiprazole in combination with sodium valproate in patients with acute manic or mixed episodes

2017 ◽  
Vol 41 (S1) ◽  
pp. S749-S749
Author(s):  
N. Amanat ◽  
A. Nazeri Astane ◽  
B. Dieji ◽  
O. Rezaie ◽  
A. Biglarian
Keyword(s):  
Weight Gain ◽  
Sodium Valproate ◽  
Rating Scale ◽  
Analysis Of Covariance ◽  
Young Mania ◽  
Double Blind ◽  
Measurement Evaluation ◽  
Significant Difference ◽  
Competing Interest ◽  
Bipolar Patients

Today, despite of the improvement in the psychological therapeutic approach, mania still remains as a challenging problem for health system. The aim of this study is comparison efficacy of risperidone and aripiprazole in combination with sodium valproate in bipolar patients with acute manic or mixed episodes who hospitalized in Razi psychiatric hospital in Tehran. This study was conducted as a double blind randomized clinical trial in two groups of bipolar disorder patients with manic or mixed episodes (18–65 age). Patients randomly set in two groups who received valproate with aripiprazole or risperidone. Clinical response was assessed with young mania rating scale (YMRS) and weight gain at 3 and 6 weeks. Data was analyzed with Chi2 test, paired t-test and analysis of covariance and repeated measurement. Evaluation of treatment response after 3 and 6 weeks (50% reduction in Young's scale) in both groups did not show any significant difference between the two therapeutic combinations. The combination of sodium valproate and risperidone showed higher weight gain in comparison with the combination of valproate and aripiprazole at the end of week 6 (P < 0.001). The mentioned combination in bipolar I disorder with manic or mixed episode has similar therapeutic effect, so that both of them are effective and usable. There was no difference in their efficacy, and both treatments can be used. Due to the less weight gain, the combination of valproate and aripiprazole in patients who prone to weight gain, this approach is recommended as more safe and effective therapy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed Feature Bipolar I Disorder: A Randomized Double-Blind Clinical Trial Study

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mercedeh Samiei ◽  
Zahra Sepehrifar ◽  
Reza Daneshmand ◽  
Gita Sadighi
Keyword(s):  
Sodium Valproate ◽  
Rating Scale ◽  
Maximum Level ◽  
Acute Mania ◽  
Therapeutic Effects ◽  
Young Mania ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Bipolar I Disorder ◽  
Significant Difference

Background: Acute mania causes many problems for the patient and others. Therefore, it is very important to eliminate the symptoms quickly. Objectives: The present study made the individual comparison of the therapeutic effects of sodium valproate combined with quetiapine or haloperidol as an add-on among patients with bipolar I disorder experiencing an episode of mania or mixed feature admitted to a Psychiatric Center in Tehran. Methods: The present study was a double-blind clinical randomized trial conducted on 36 patients. All patients were investigated by the Young Mania Rating Scale (YMRS). The study lasted six weeks in total (after raising drug dosage to the maximum level). We prescribed sodium valproate 15 mg/kg plus quetiapine 500 mg daily in one group and sodium valproate 15 mg/kg plus haloperidol 10 mg daily in the other group. In addition, an equivalent dosage of quetiapine and haloperidol was prescribed. This study used different data analysis methods such as Paired t test, ANOVA, and chi-square test. Results: The YMRS scores did not show any statistically significant difference between quetiapine and haloperidol receiving groups (P > 0.05). Conclusions: This paper argued that a combination of sodium valproate with either quetiapine or haloperidol could be effective in the management of acute mania or mixed bipolar I disorder to reduce the severity and duration of symptoms, although there was no statistically significant difference between the efficacy of these two pharmacological therapies.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S1) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Psychosocial functioning impairment in euthymic patients with bipolar disorder II: The role of clinical factors

2016 ◽  
Vol 33 (S1) ◽  
pp. S333-S333
Author(s):  
R.S. Ilhan ◽  
V. Senturk-Cankorur
Keyword(s):  
Bipolar Disorder ◽  
Psychosocial Functioning ◽  
Rating Scale ◽  
Healthy Individuals ◽  
Young Mania ◽  
Clinical Variables ◽  
Hamilton Anxiety Rating Scale ◽  
Short Test ◽  
Competing Interest ◽  
Bipolar Patients

IntroductionGrowing body of evidence have showed that euthymic bipolar patients have poor psychosocial functioning. Most of the studies have focused on the psychosocial functioning in euthymic bipolar disorder (BD)-I patients. On the contrary, there have been limited researches investigating psychosocial functioning in euthymic BD-II patients. Moreover, the factors associated with psychosocial functioning in euthymic patients with BD II have been also understudied.Objectives/aimsAim of our study was to investigate the association between clinical variables and poor psychosocial functioning in euthymic BD-II patients. Hypothesis of this study was that euthymic BD-II patients would have low level of psychosocial functioning compared with healthy individuals.MethodsBD-II (n = 37) and healthy subjects (n = 35) were compared in terms of their psychosocial functioning which were assessed by Functional Assessment Short Test (FAST). The euthymic state was confirmed by low scores both on the Hamilton Depression Rating Scale (HDRS) and the Young Mania Rating Scale (YMRS). Anxiety symptoms were also assessed by Hamilton Anxiety Rating Scale (HARS) in both groups. Clinical variables were taken as independent variables and FAST scores were taken as dependent variable in order to run correlation analysis in BD-II group.ResultsNo socio-demographic differences were found between two groups. Euthymic BD-II patients had significantly higher FAST, HARS, HDRS YMRS scores compared with healthy individuals. Only HDRS scores correlated with FAST scores of BD-II patients.ConclusionsThis study indicated that euthymic BD-II patients had poorer psychosocial functioning. And subclinical depressive symptoms were associated with poor psychosocial functioning.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Efficacy Of Lurasidone In Major Depression With Mixed Features: Pattern Of Improvement In Depressive And Manic Symptoms

2016 ◽  
Vol 33 (S1) ◽  
pp. S423-S423
Author(s):  
A.A. Nierenberg ◽  
J. Tsai ◽  
Y. Mao ◽  
A. Pikalov ◽  
T. Suppes ◽  
...  
Keyword(s):  
Rating Scale ◽  
Depression Score ◽  
Effect Sizes ◽  
Young Mania ◽  
Double Blind ◽  
Manic Symptoms ◽  
Depression Subscale ◽  
Mixed Features ◽  
Competing Interest ◽  
Depressive And Manic Symptoms

IntroductionEvidence indicates that manic symptoms, below the threshold for hypomania (mixed features), are common in individuals with major depressive disorder (MDD).Objectives/aimsTo evaluate the effect of lurasidone on specific depressive and manic symptoms, based on Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) items, in patients with MDD with mixed features.MethodsPatients meeting DSM-IV-TR criteria for MDD, who presented with 2–3 protocol-specified manic symptoms, were randomized to 6 weeks of double-blind treatment with lurasidone monotherapy 20–60 mg/d (n = 109) or placebo (n = 100). Change from baseline in the MADRS total, MADRS-6 core depression subscale, individual MADRS items, and total and individual items of the YMRS were analyzed by MMRM, and Cohen's d effect sizes (d) were calculated for week 6 change scores.ResultsLurasidone improved depressive symptoms at week 6 in the MADRS total score (–20.5 vs. –13.0; P < 0.0001; d = 0.8) and MADRS-6 core depression score (–13.0 vs. –8.5; P < 0.0001; d = 0.7). Significant improvement on lurasidone was observed at week 6 on all ten MADRS items (d = 0.36–0.78). Effect sizes for the MADRS-6 core depression subscale items ranged from 0.36 to 0.78 at week 6. Treatment with lurasidone was associated with significantly greater week 6 improvement on the YMRS (–7.0 vs. –4.9; P < 0.0001). Effect sizes for the 5 YMRS items with baseline item severity ≥ 2 ranged from 0.32 to 0.48.ConclusionsIn this study of MDD with mixed features, lurasidone was effective in treating the range of depressive and manic symptoms that patients presented with.Sponsored by Sunovion Pharmaceuticals Inc.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Celecoxib added to mood stabilizer for treating acute mania in bipolar disorder: A randomized, double -blind, placebo-controlled trial in IRAN

2021 ◽  
Author(s):  
Farhad Faridhosseini ◽  
Ali Talaei ◽  
Najmeh Shahini ◽  
Mahbobeh Eslamzadeh ◽  
Samira Ahrari ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Acute Mania ◽  
Control Group ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Valproate Sodium ◽  
Significant Difference

Abstract Background: Inflammatory processes in the brain contribute to the aetiopathogenesis of acute mania. Cyclooxygenase-2 (COX-2) inhibitors, such as Celecoxib, reduce the production of pro-inflammatory cytokines. The purpose of the present investigation was to assess the efficacy of Celecoxib in the treatment of acute mania.Methods: We conducted a double-blind, placebo-controlled trial at the Specialty in-patient Clinic of Ibn-e-Sina Hospital [Mashhad University of Medical Sciences, Iran] from March 2017 to August 2017. The study involved 58 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for acute mania screening to participate in the trial were used for the study. Twenty-three patients were assigned to a study group and were given Valproate Sodium 200 mg /BD plus Celecoxib 400 mg/day (200 mg BID). The control group included 22 patients who were given Valproate Sodium 200 mg /BD plus placebo. Patients were assessed by Young Mania Rating Scale (YMRS) at baseline 0, after 9, 18, and 28 days after the medication started. Data were analyzed by using Statistical Package for Social Sciences (SPSS) 11.5., two-way repeated measures analysis of variance, Fisher’s exact test, and T-Test. P≤0.05 was considered to be statistically significant.Results: A total of 58 patients were screened and 45 were randomized. Most of participations in celecoxib group were male (55%) and in placebo group were female (75%). There were no statistically significant differences between the groups regarding number of episode. sex, marital status, past medical history, past psychiatry history and family history P value ≥0.05. A significant difference was observed in the change of scores on Young Mania Rating Scale (YMRS) at week 4 as compared to the baseline in patient groups P: 0.04.Conclusion: This study suggested that Celecoxib can be an effective adjuvant agent in managing patients with acute mania and anti-inflammatory therapies should further be investigated in these patients.Trial registration: Iran clinical trial register: IRCT20200306046708N1

Haloperidol, risperidone and quetiapine in the treatment of acute severe manic episode in bipolar disorder: The experience at the mood disorder unit in Milan

2016 ◽  
Vol 33 (S1) ◽  
pp. S121-S121
Author(s):  
D. Delmonte ◽  
C. De Santis ◽  
S. Brioschi ◽  
B. Barbini ◽  
C. Colombo
Keyword(s):  
Repeated Measures ◽  
Best Practice ◽  
Rating Scale ◽  
Manic Episode ◽  
Drug Dose ◽  
Mood Stabilizers ◽  
Young Mania ◽  
Double Blind ◽  
Competing Interest ◽  
Double Blind Design

IntroductionPatients affected by severe manic episode, often with delusional symptoms, are commonly treated with a combination of mood stabilizers, antipsychotics and other sedatives. The choice of a specific drug, dose and term is still debated.ObjectivesA naturalistic study on a sample of 84 inpatients affected by acute severe mania treated with a combination therapy.AimsTo compare efficacy and tolerability of haloperidol/risperidone/quetiapine in association with lithium and/or valproate.MethodsEighty-four bipolar inpatients affected by a manic episode according to DSM-5 criteria. Drugs administered according to our best practice. Clinical course weekly monitored with Young Mania Rating Scale (YMRS) for 4weeks. Extrapiramidal side effects (EPSE) monitored with Saint Hans Rating Scale (SHRS).ResultsTwenty-five men (29.76%) and 59 women (70.24%); mean age 43.37 ± 13.58 years. Mean YMRS score T0 40.27 ± 9.04. Forty-one patients (48.81%) treated with haloperidol (3.4 mg/die); 16 (19.05%) with risperidone (4.3 mg/die); 27 (32.14%) with quetiapine (438 mg/die). The 3 groups showed no difference regarding clinical characteristics and YMRS basal scores. Chi2 analysis confirmed an higher response rate (50% of reduction of YMRS final score compared to T0) with haloperidol (χ2 = 14.88; P = 0.00). The repeated-measures model analysis showed a significant decrease (P < 0.05) in YMRS scores in haloperidol vs. risperidone vs. quetiapine patients for all time points from second week. No statistical difference for EPSE was found.ConslusionsWe suggest that haloperidol could be advisable in the treatment of severe mania, with rapid efficacy, even with low doses. Occurrence of EPSE was not considerable during the acute treatment. Studies with a larger sample size, randomization, fixed doses, double blind design are needed.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals The effect of adding curcumin to sodium valproate in treatment of patients with bipolar disorder in the acute phase of mania: a clinical trial.

2020 ◽  
Author(s):  
Farzad Akbarzadeh ◽  
Nabahat Niksun ◽  
Fatemeh Behdani ◽  
Amir Hoshang Mohammadpour ◽  
Mahmoudreza Jaafari ◽  
...  
Keyword(s):  
Sodium Valproate ◽  
Control Group ◽  
P Value ◽  
Double Blind Study ◽  
Young Mania ◽  
Double Blind ◽  
Diagnostic And Statistical Manual ◽  
New Therapeutic Approaches ◽  
Significant Difference ◽  
Inflammatory Processes

Abstract Background: Inflammatory processes in the brain play an important role in etiopathogenesis of many psychiatric disorders including, bipolar mood disorder (BMD) as a life-long episodic disease. An inefficient therapeutic intervention especially for resistant cases makes the necessity of doing more precise investigation to find out new therapeutic approaches apparent. This double-blind study aims to investigate the effect of Crucumin as anti-inflammatory herbal based drug in the treatment of BMD. Results: 78 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for BMD screening to participate in the trial. The participants included 32 patients in the placebo group receiving sodium valproate and crucumin and 38 patients in the control group receiving placebo and sodium valproate. At the beginning of the study and weeks 1, 2, 4 the patients were assessed by a psychiatrist using Young mania score (YMRS). Fifty four patients completed the trial. Mean age in patients group was 36.28±10.73 and in control group was 32.42 ±9.60.Clinical characteristics of the patients, such as age, did not differ between groups P value ≥0.05. Results showed the process of changes were significant different in both group. The results showed that the changes in the resultss of YMRS, MMSE and CGI scores were significant in each group (P value≤0.001), but no significant difference has been detected between the two groups (p≥0.05).Conclusions: this study suggested that crucumin cannot be an effective adjuvant agent in management of patients with BMD under treatment with sodium valproate.

scholarly journals Creatine kinase levels in patients with bipolar disorder: depressive, manic, and euthymic phases

2011 ◽  
Vol 33 (2) ◽  
pp. 171-175 ◽  
Author(s):  
Gustavo Feier ◽  
Samira S. Valvassori ◽  
Gislaine T. Rezin ◽  
Márcio Búrigo ◽  
Emilio L. Streck ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Creatine Kinase ◽  
Healthy Volunteers ◽  
Rating Scale ◽  
Serum Creatine Kinase ◽  
Control Group ◽  
Young Mania ◽  
Potential Marker ◽  
Significant Difference ◽  
Bipolar Patients

OBJECTIVE: Bipolar disorder is a severe, recurrent, and often chronic psychiatric illness associated with significant functional impairment, morbidity, and mortality. Creatine kinase is an important enzyme, particularly for cells with high and fluctuating energy requirements, such as neurons, and is a potential marker of brain injury. The aim of the present study was to compare serum creatine kinase levels between bipolar disorder patients, in the various phases (depressive, manic, and euthymic), and healthy volunteers. METHOD: Forty-eight bipolar patients were recruited: 18 in the euthymic phase; 17 in the manic phase; and 13 in the depressive phase. The control group comprised 41 healthy volunteers. The phases of bipolar disorder were defined as follows: euthymic-not meeting the DSM-IV criteria for a mood episode and scoring < 8 on the Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS); manic-scoring < 7 on the HDRS and > 7 on the YMRS; depressive-scoring > 7 on the HDRS and < 7 on the YMRS. Patients in mixed phases were excluded. Blood samples were collected from all participants. RESULTS: Creatine kinase levels were higher in the manic patients than in the controls. However, we observed no significant difference between euthymic and depressive patients in terms of the creatine kinase level. CONCLUSION: Our results suggest that the clinical differences among the depressive, manic, and euthymic phases of bipolar disorder are paralleled by contrasting levels of creatine kinase. However, further studies are needed in order to understand the state-dependent differences observed in serum creatine kinase activity.

scholarly journals Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Placebo Group ◽  
Adverse Effects ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Controlled Clinical Trial ◽  
Young Mania ◽  
Double Blind ◽  
Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

Sign in / Sign up

Export Citation Format

Share Document